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Developing Solid Oral Dosage Forms

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Developing Solid Oral Dosage Forms

Developing Solid Oral Dosage Forms Book
Author : Yihong Qiu,Yisheng Chen,Geoff G.Z. Zhang,Lawrence Yu,Rao V. Mantri
Publisher : Academic Press
Release : 2016-11-08
ISBN : 0128026375
Language : En, Es, Fr & De

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Book Description :

Developing Solid Oral Dosage Forms: Pharmaceutical Theory and Practice, Second Edition illustrates how to develop high-quality, safe, and effective pharmaceutical products by discussing the latest techniques, tools, and scientific advances in preformulation investigation, formulation, process design, characterization, scale-up, and production operations. This book covers the essential principles of physical pharmacy, biopharmaceutics, and industrial pharmacy, and their application to the research and development process of oral dosage forms. Chapters have been added, combined, deleted, and completely revised as necessary to produce a comprehensive, well-organized, valuable reference for industry professionals and academics engaged in all aspects of the development process. New and important topics include spray drying, amorphous solid dispersion using hot-melt extrusion, modeling and simulation, bioequivalence of complex modified-released dosage forms, biowaivers, and much more. Written and edited by an international team of leading experts with experience and knowledge across industry, academia, and regulatory settings Includes new chapters covering the pharmaceutical applications of surface phenomenon, predictive biopharmaceutics and pharmacokinetics, the development of formulations for drug discovery support, and much more Presents new case studies throughout, and a section completely devoted to regulatory aspects, including global product regulation and international perspectives

Developing Solid Oral Dosage Forms

Developing Solid Oral Dosage Forms Book
Author : Yihong Qiu,Yisheng Chen,Geoff G.Z. Zhang,Lirong Liu,William Porter
Publisher : Academic Press
Release : 2009-03-10
ISBN : 9780080932729
Language : En, Es, Fr & De

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Book Description :

Developing Solid Oral Dosage Forms is intended for pharmaceutical professionals engaged in research and development of oral dosage forms. It covers essential principles of physical pharmacy, biopharmaceutics and industrial pharmacy as well as various aspects of state-of-the-art techniques and approaches in pharmaceutical sciences and technologies along with examples and/or case studies in product development. The objective of this book is to offer updated (or current) knowledge and skills required for rational oral product design and development. The specific goals are to provide readers with: Basics of modern theories of physical pharmacy, biopharmaceutics and industrial pharmacy and their applications throughout the entire process of research and development of oral dosage forms Tools and approaches of preformulation investigation, formulation/process design, characterization and scale-up in pharmaceutical sciences and technologies New developments, challenges, trends, opportunities, intellectual property issues and regulations in solid product development The first book (ever) that provides comprehensive and in-depth coverage of what's required for developing high quality pharmaceutical products to meet international standards It covers a broad scope of topics that encompass the entire spectrum of solid dosage form development for the global market, including the most updated science and technologies, practice, applications, regulation, intellectual property protection and new development trends with case studies in every chapter A strong team of more than 50 well-established authors/co-authors of diverse background, knowledge, skills and experience from industry, academia and regulatory agencies

FDA Quality Standards for Generic Drug Products

FDA Quality Standards for Generic Drug Products Book
Author : Susan M. Rosencrance,Lawrence Yu
Publisher : Academic Press
Release : 2018-03-01
ISBN : 0128112158
Language : En, Es, Fr & De

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Book Description :

FDA Quality Standards for Generic Drug Products features the history and evolution of the FDA’s generic drug program, along with an overview of the quality assessment process performed by the FDA and an in-depth look at quality standards for a variety of dosage forms. Chapters cover important topics such as quality by design, the ANDA structure, CMC, process analytical technology and other emerging technologies, design of experiments and statistics and the similarities and differences between the FDA and international regulatory agencies. Edited and written by experienced leaders in the field, this book contains case studies throughout and provides insider perspectives on what the future may hold for generic drugs. An essential resource for pharmaceutical, regulatory and academic scientists, this book can be used to establish the necessary procedures and specifications in order to seek approval to develop quality products more quickly and easily. Highlights recent developments regarding quality by design and quality standards associated with particular dosage forms, including complex generic drug products Offers an overview of the FDA’s current assessment process for ANDAs, from filing to approval, and discuses important considerations regarding post-approval changes and lifecycle management Written by FDA scientists who actively review ANDAs and develop regulatory policies associated with generic drugs

Drug Topics

Drug Topics Book
Author : Anonim
Publisher : Unknown
Release : 1980
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download Drug Topics book written by , available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

The Chemical Engineer

The Chemical Engineer Book
Author : Anonim
Publisher : Unknown
Release : 2005
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download The Chemical Engineer book written by , available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Sample Preparation of Pharmaceutical Dosage Forms

Sample Preparation of Pharmaceutical Dosage Forms Book
Author : Beverly Nickerson
Publisher : Springer Science & Business Media
Release : 2011-08-05
ISBN : 9781441996312
Language : En, Es, Fr & De

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Book Description :

This book is intended to serve as a resource for analysts in developing and troubleshooting sample preparation methods. These are critical activities in providing accurate and reliable data throughout the lifecycle of a drug product. This book is divided into four parts: • Part One covers dosage form and diluent properties that impact sample preparation of pharmaceutical dosage forms and the importance of sampling considerations in generating data representative of the drug product batch. • Part Two reviews specific sample preparation techniques typically used with pharmaceutical dosage forms. • Part Three discusses sample preparation method development for different types of dosage forms including addressing drug excipient interactions and post extraction considerations, as well as method validation and applying Quality by Design (QbD) principles to sample preparation methods. • Part Four examines additional topics in sample preparation including automation, investigating aberrant potency results, green chemistry considerations for sample preparation and the ideal case where no sample preparation is required for sample analysis.

The British National Bibliography

The British National Bibliography Book
Author : Arthur James Wells
Publisher : Unknown
Release : 2009
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

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The United States Pharmacopeial Convention Inc

The United States Pharmacopeial Convention  Inc Book
Author : United States Pharmacopeial Convention
Publisher : Unknown
Release : 1993
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

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Introduction to Pharmaceutical Dosage Forms

Introduction to Pharmaceutical Dosage Forms Book
Author : Howard C. Ansel
Publisher : Unknown
Release : 1985
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download Introduction to Pharmaceutical Dosage Forms book written by Howard C. Ansel, available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Formulation and Analytical Development for Low Dose Oral Drug Products

Formulation and Analytical Development for Low Dose Oral Drug Products Book
Author : Jack Zheng
Publisher : John Wiley & Sons
Release : 2009-03-04
ISBN : 9780470386354
Language : En, Es, Fr & De

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Book Description :

There are unique challenges in the formulation, manufacture, analytical chemistry, and regulatory requirements of low-dose drugs. This book provides an overview of this specialized field and combines formulation, analytical, and regulatory aspects of low-dose development into a single reference book. It describes analytical methodologies like dissolution testing, solid state NMR, Raman microscopy, and LC-MS and presents manufacturing techniques such as granulation, compaction, and compression. Complete with case studies and a discussion of regulatory requirements, this is a core reference for pharmaceutical scientists, regulators, and graduate students.

Problems in Pediatric Drug Therapy

Problems in Pediatric Drug Therapy Book
Author : Louis A. Pagliaro,Ann M. Pagliaro
Publisher : American Pharmaceutical Association
Release : 1995
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

This reference volume addresses distinct pharmaceutical care issues for all paediatric age ranges, from neonatal to adolescent. This third edition of the text includes two new chapters covering: paediatric pharmocokinetics and abusable psychtropic drugs.

Comprehensive Pharmacy Review

Comprehensive Pharmacy Review Book
Author : Leon Shargel,Alan H. Mutnick,Paul F. Souney,Larry N. Swanson
Publisher : Lippincott Raven
Release : 2001
ISBN : 9780781721479
Language : En, Es, Fr & De

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Book Description :

This thoroughly-updated edition features contributions from more than 24 specialists, and reflects the current progress in pharmacy education and practice. Written for pharmacy students who are preparing for the NAPLEX test, and for pharmacy undergraduates and professionals who need detailed summaries of pharmacy subjects, this study guide covers chemistry, pharmaceutics, pharmacology, pharmacy practice, drug therapy, and other topics. A separate booklet of simulated NAPLEX exams supplements this review, and provides reliable test practice. Chapters are organized to parallel the pharmacy curriculum and appear in outline form for easy use. Appendices include prescription dispensing information, common prescription drugs, and general pharmacy references. It can be used by a diverse group of readers, including the following: Matriculating pharmacy students who often require such a text in their freshman year to help them prepare for course examinations / Instructors and preceptors who can use the chapter outlines to help organize courses and plan specific lectures / Professional pharmacists who can use a convenient handbook of pharmacy facts and up-to-date information

Handbook of Common Stocks

Handbook of Common Stocks Book
Author : Anonim
Publisher : Unknown
Release : 2000
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

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Dissolution Shelf life of Unpackaged Solid Oral Drug Products

Dissolution Shelf life of Unpackaged Solid Oral Drug Products Book
Author : Sheau-shya Wu
Publisher : Unknown
Release : 1996
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download Dissolution Shelf life of Unpackaged Solid Oral Drug Products book written by Sheau-shya Wu, available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Ansel s Pharmaceutical Dosage Forms and Drug Delivery Systems

Ansel s Pharmaceutical Dosage Forms and Drug Delivery Systems Book
Author : Loyd V. Allen,Nicholas G. Popovich,Howard C. Ansel
Publisher : Unknown
Release : 2011
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

"Thanks to its comprehensive coverage, clear explanations, and logical organization, Ansel's Pharmaceutical Dosage Forms and Drug Delivery Systems has been a core pharmaceutics text in the pharmacy curriculum for more than 40 years. As you progress through this thoroughly updated Ninth Edition, you'll master all the principles, practices, and technologies essential for the preparation of pharmaceutical dosage forms and drug delivery systems. The text's integrated approach will help you understand the interrelationships among pharmaceutical and biopharmaceutical principles, product design, formulation, manufacturing, compounding, and the clinical application of dosage forms for effective patient care." --Book Jacket.

Bulk Solids Handling

Bulk Solids Handling Book
Author : Anonim
Publisher : Unknown
Release : 1994
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

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New Scientist

New Scientist Book
Author : Anonim
Publisher : Unknown
Release : 2002
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download New Scientist book written by , available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Dissertation Abstracts International

Dissertation Abstracts International Book
Author : Anonim
Publisher : Unknown
Release : 2007
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download Dissertation Abstracts International book written by , available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

USP DI

USP DI Book
Author : Anonim
Publisher : Physician's Desk Reference (PDR)
Release : 2005
ISBN : 9781563635168
Language : En, Es, Fr & De

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Book Description :

Download USP DI book written by , available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Drug Interaction and Clinical Pharmacy

Drug Interaction and Clinical Pharmacy Book
Author : Anonim
Publisher : Unknown
Release : 1990
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download Drug Interaction and Clinical Pharmacy book written by , available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.